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AU2001266460B2 - Method and device for preparation of bone cement - Google Patents

Method and device for preparation of bone cement Download PDF

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Publication number
AU2001266460B2
AU2001266460B2 AU2001266460A AU2001266460A AU2001266460B2 AU 2001266460 B2 AU2001266460 B2 AU 2001266460B2 AU 2001266460 A AU2001266460 A AU 2001266460A AU 2001266460 A AU2001266460 A AU 2001266460A AU 2001266460 B2 AU2001266460 B2 AU 2001266460B2
Authority
AU
Australia
Prior art keywords
bone cement
mixing chamber
extrusion
sleeve
vacuum
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
AU2001266460A
Other versions
AU2001266460A1 (en
Inventor
Soren Jonsson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cemvac System AB
Original Assignee
Cemvac System AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cemvac System AB filed Critical Cemvac System AB
Publication of AU2001266460A1 publication Critical patent/AU2001266460A1/en
Application granted granted Critical
Publication of AU2001266460B2 publication Critical patent/AU2001266460B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8827—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it with filtering, degassing, venting or pressure relief means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F31/00—Mixers with shaking, oscillating, or vibrating mechanisms
    • B01F31/44—Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement
    • B01F31/441—Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement performing a rectilinear reciprocating movement
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5014—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use movable by human force, e.g. kitchen or table devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/30—Driving arrangements; Transmissions; Couplings; Brakes
    • B01F35/32—Driving arrangements
    • B01F35/32005—Type of drive
    • B01F35/3202—Hand driven
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75—Discharge mechanisms
    • B01F35/754—Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/75425—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers
    • B01F35/754251—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers reciprocating in the mixing receptacle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3015—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments transparent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4685—Special tools for implanting artificial joints by means of vacuum

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Curing Cements, Concrete, And Artificial Stone (AREA)

Description

O1
O
0Method and device for preparation of bone cement Z BACKGROUND OF THE INVENTION The present invention relates to a method for preparing bone cement.
0 The invention also relates to a device for preparing bone cement.
SWhen preparing bone cement it is important, considering the future strength of the 0 O 10 bone cement, to achieve a bone cement which is as free as possible from pores and the like caused by air or gas inclusions. These inclusions may be caused by remaining air and gases, occurring when mixing the components of the bone cement, which during the mixing procedure are mixed into the bone cement mass.
From SE-9200360-7 it is previously known how to collect dispersed bone cement, by means of the movement occurring under the influence of vacuum in the mixing chamber when the movable wall section is set free, to form a bone cement pillar in the evacuation section of the mixing chamber. To prevent air, to the extent possible, from leaking in one or several O-rings are arranged around the movable wall section. The O-rings will cause an increased friction implying that the movement of the movable section as well as the collection of bone cement thereby will be poor or prevented when the sealing causes too high friction. Consequently it can be stated, for known devices or methods for preparation of bone cement, that it must be accepted to allow some air or gas inclusions.
SUMMARY OF THE INVENTION The object of the present invention is to produce improved removal of air and gas inclusions in the bone cement. In addition assurance is attained that the movable wall section always will be moved and that thereby improved collection of bone cement is obtained. In one aspect of the invention, a method for preparing bone cement is provided. The constituent components of the bone cement are mixed under vacuum la
O
0 in a closed mixing chamber which is formed with a movable wall section that is fixed o during the mixing process. After mixing is finished, extrusion of bone cement is Z performed by releasing the movable wall section and bringing the movable wall section towards an extrusion opening. As the movable wall section is brought towards the extrusion opening, the bone cement is compressed.
0 In another aspect of the invention, a device for preparing bone cement is provided.
ID The device includes a mixing chamber equipped with a vacuum connection, a wall Ssection that is movable in the direction of the opposite part of the mixing chamber, and a device arranged to maintain the movable wall section in its initial position during the mixing process. An extrusion opening is located opposite to the movable wall section of the mixing chamber and a sealing device is arranged to openably seal the extrusion opening. Further, an extrusion tool is arranged to apply a force towards the movable wall section to perform the extrusion. Prior to extrusion, the extrusion opening is sealed by the sealing device for compression of the bone cement.
WO 02/102286 PCT/SE01/01345 2 BRIEF DESCRIPTION OF THE DRAWING In the following the invention will be explained in more detail by means of examples of embodiments of the present invention and with reference to the accompanying drawing.
Fig. 1 a illustrates a mixing chamber, in accordance with the invention, during mixing of the constituent components of bone cement. In Figs. Ib-le a number of phases are illustrated when the mixing chamber is introduced into a sleeve of an extrusion tool.
Fig. 2a and Fig. 2b illustrate how the compression and extrusion procedures respectively are carried out by means of the extrusion tool. In Fig. 3 the movement of the bone cement in the mixing chamber during the extrusion process is illustrated. Fig.
4a-4c illustrate three different embodiments, according to the invention, of a sleeve integral with said extrusion tool. In Fig. 5 the mixing chamber is illustrated introduced into an alternative embodiment of the sleeve designed with a cut-out.
In the drawing designation 1 indicates a mixing chamber and 2 a moveable wall section, which is detachably fixed in its initial position by means of a locking pin 3. The mixing chamber 1 is equipped with a vacuum connection 4 and an agitator device.
The agitator device comprises of an agitator rod 5 with an axial extrusion channel for bone cement and an agitator 6 arranged around the end of agitator rod 5 within mixing chamber 1. The agitator rod 5 and the mixing chamber 1 are for reasons, which will be apparent later, preferably made from a transparent material.
The agitator rod 5 is axially moveable in mixing chamber 1 through opening 7 which is sealed against agitator rod 5. The orifice of the channel of agitator rod 5, in mixing chamber 1, forms an extrusion opening 8 for bone cement at agitator 6. During mixing a sealing rod 9 is inserted into the channel of agitator rod 5 to seal extrusion opening 8. Flow line 10 illustrates the path of the bone cement during compression and extrusion processes at which the bone cement passes a filter 11 arranged in connection with vacuum connection 4.
The device according to the invention also comprises an extrusion tool 12 with a sleeve 13a and an extrusion pistol 14. Sleeve 13a is formed with an opening 15 for introduction of mixing chamber 1, an opening 16 for agitator rod 5, two grooves 17 for locking pin 3 and an opening 18 for vacuum connection 4.
WO 02/102286 PCT/SE01/01345 3 DESCRIPTION OF THE INVENTION Mixing chamber 1 is, when preparing bone cement, used to mix the constituent cement components under vacuum. The bone cement components are introduced into mixing chamber 1 after which agitator rod 5 of the agitator device, is axially moved in and out of mixing chamber 1, and preferably turned at the same time through opening 7. The actual mixing is performed by agitator 6, arranged around the end of agitator rod 5 within mixing chamber 1, since it is turned and moved among the bone cement components by means of the previously mentioned movement of agitator rod During the entire mixing process extrusion opening 8 in association with the agitator 6 will come into contact with the bone cement. Leakage of bone cement out of and air into mixing chamber 1 via extrusion opening 8 is prevented during mixing by sealing rod 9.
When it is established that the bone cement components are sufficiently mixed the device is prepared for bone cement extrusion. The agitator rod 5 is then moved out of mixing chamber 1 as far as possible at which agitator 6 and extrusion opening 8 connect to the wall, located opposite to the moveable wall section 2 of mixing chamber 1. The extrusion process, wherein the bone cement is moved out of mixing chamber 1 through extrusion opening 8 and into the channel of agitator rod 5 functioning thereby as a nozzle, may then start.
Compression of the bone cement is, according to the present invention, performed before extrusion. The object with the compression is to squeeze remaining air and gas inclusions out of said bone cement to achieve as compact a material as possible.
Both compression and extrusion are performed by means of extrusion tool 12, which is similar to a spray pistol for sealing compounds or similar, and sleeve 13a, in which mixing chamber 1 is placed after finished mixing.
Mixing chamber 1 is inserted into sleeve 13a through opening 15 and placed inside sleeve 13a such that agitator rod 5, when completely pulled out, is sticking out of sleeve 13a through opening 16. Sleeve 13a is formed with grooves 17 to keep locking pin 3, and thus the movable wall section 2, in its initial position during the insertion. The side wall of sleeve 13a is formed such that vacuum connection 4 has to be removed before insertion, however opening 18 allows for reconnection of vacuum connection 4 after insertion. The phases in relation to insertion of mixing chamber 1 into sleeve 13a are illustrated in Fig. lb-e.
WO 02/102286 PCT/SE01/01345 4 When mixing chamber 1 is placed inside sleeve 13a of extrusion tool 12, vacuum connection 4 is reconnected and the moveable wall section is set free by means of the locking pin 3 being removed. These phases are illustrated in Fig. d-e. The extrusion pistol 14 of extrusion tool 12 is thereafter connected to sleeve 13a and the actual compression of the bone cement may start.
The compression, which also is performed under vacuum, is executed by a force applied by means of extrusion pistol 14, against the moveable wall section 2 such that it is moved towards extrusion opening 8. The bone cement will then move along the flow lines 10, illustrated in Fig. 3, and be compressed towards extrusion opening 8.
Passing towards extrusion opening 8 the bone cement will come into contact with filter 11 while air and gas inclusions are exhausted by suction through vacuum connection 4. After compression to a certain degree the bone cement will push sealing rod 9, which seals extrusion opening 8, ahead of the bone cement and out of the channel of agitator rod 5, in which bone cement in the shape of a column is formed.
When desired length of the bone cement column is obtained, agitator rod 5 is cut off at the front of the obtained bone cement colunm just at or ahead of the sealing rod 9.
The extrusion and application of the bone cement may then be performed. Fig. 2a and 2b illustrate the compression and extrusion processes while mixing chamber 1 is placed inside sleeve 13a and connected to extrusion pistol 14.
The present invention also comprises two alternative embodiments, 13b and 13c, of the sleeve of extrusion tool 12, these are illustrated in Fig. 4b and 4c.
In the sidewall of sleeve 13b a groove 17 and a cut-out 19 are formed. The cut-out 19 extends along most of the wall of sleeve 13b, with the aim to prevent the vacuum connection 4 from having to be removed before the insertion of mixing chamber 1.
The vacuum connection 4 may thereby be kept during mixing, subsequent compression and extrusion processes, which are similar to the process described in relation to sleeve 13a. Furthermore the cut-out 19 and the groove 17 imply that the locking pin 3 may be kept during the insertion too. Fig. 5 illustrates the mixing chamber 1 inserted into sleeve 13b.
Sleeve 13e is formed without any groove or cut-out in the side wall, which means that this sleeve is used when both vacuum connection 4 and locking pin 3 are removed before the insertion of mixing chamber 1. However, sleeve 13e is formed with an opening 18 in order to allow vacuum connection 4 to be reconnected prior to WO 02/102286 PCT/SE01/01345 subsequent compression and extrusion processes, which are performed in the same way as when sleeve 13a or 13b is used.
Common factors for the three sleeves 13a-c according to the invention, are that their interior is formed such that it is adjusted to the form of mixing chamber 1, this by having opening 15 for insertion of mixing chamber 1 and opening 16 for agitator rod and that anyone of them may be used for an extrusion process performed under vacuum. However, the three sleeves 13a-c differ from each other in whether they allow vacuum connection 4 and locking pin 3 to be kept in place during insertion of the mixing chamber 1, which will result in differing influences on the moveable wall section 2 in the process after insertion.
A negative pressure will arise in the mixing chamber 1 when the vacuum connection 4 is connected. This implies that the moveable wall section 2 will be influenced of the vacuum to be sucked into the mixing chamber 1. If the moveable wall section 2 is set free when vacuum connection 4 is connected, which is the case at reconnection of the vacuum connection 4 after insertion of the mixing chamber 1 into sleeve 13e, the moveable wall section 2 will be sucked into the mixing chamber 1. When the mixing chamber 1 is placed in sleeve 13a or 13b the moveable wall section 2 is, despite the influence of the vacuum, kept in its initial position by the locking pin 3 and can therefore not be moved before removing locking pin 3.
It is apparent, for anyone skilled in the art, that the present invention is not restricted to the above-described embodiments. For example extrusion may also be performed by means of an extrusion tool assuming other embodiments than mentioned above.

Claims (7)

1- to form bone cement; and extruding the bone cement from the mixing chamber by actuating the wall section toward the extrusion opening, wherein the extruding of the bone cement is performed 0 under maintained vacuum in the mixing chamber.
2. A method for preparation of bone cement, comprising: providing a closed mixing chamber having a detachably fixed wall section that is moveable within the chamber, an extrusion nozzle defining an extrusion opening, and a sealing device arranged within the extrusion nozzle and sealing the extrusion opening; mixing constituent components of bone cement under vacuum in the mixing chamber to form bone cement; compressing the bone cement in the mixing chamber by actuating the wall section toward the extrusion opening with the sealing device arranged in the extrusion nozzle, 2 0 wherein during compression the sealing device is forced partially out of the extrusion nozzle by a column of bone cement that is formed in the extrusion nozzle; terminating compression after a desired length of the column of bone cement is formed; and cutting the extrusion nozzle off just ahead of the front of the column of bone cement.
3. The method of claim 2, wherein the compression of the bone cement is performed under maintained vacuum in the mixing chamber.
4. A device for preparing and extruding bone cement, comprising: a mixing chamber equipped with a vacuum connection for connection to a vacuum source, the mixing chamber having an extrusion opening and a moveable wall section within the mixing chamber and moveable toward the extrusion opening; a device configured and arranged to maintain the moveable wall section at an initial POSITION during mixing of bone cement constituents in the mixing chamber; a sealing device configured and arranged to seal the extrusion opening; and 7 O an extrusion tool that includes a sleeve that is configured and arranged to receive the >mixing chamber, and a mechanism that is configured and arranged to apply an Z actuating force to the moveable wall section to perform extrusion, and wherein the sleeve is configured and arranged to allow the connection between the vacuum source and the vacuum connection to be maintained during extrusion of the bone cement. o
5. The device of claim 4, wherein the sleeve has two grooves formed therein that are configured and arranged to enable the device to keep the moveable Iwall section at its initial position during insertion of the mixing chamber into the csleeve, and the sleeve further includes an opening that allows the vacuum source to be reconnected to the vacuum connection after insertion.
6. The device of claim 4, wherein the sleeve has a cut-out that is configured and arranged to enable the connection between the vacuum connection and the vacuum source to be maintained during insertion of the mixing chamber into the sleeve, and the sleeve includes a groove that is configured and arranged to enable the device to keep the moveable wall section at its initial position during insertion of the mixing chamber into the sleeve.
7. The device of claim 4, wherein the sleeve includes an opening that allows the vacuum source to be reconnected to the vacuum connection after insertion of the mixing chamber into the sleeve.
AU2001266460A 2001-06-14 2001-06-14 Method and device for preparation of bone cement Ceased AU2001266460B2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2001/001345 WO2002102286A1 (en) 2001-06-14 2001-06-14 Method and device for preparation of bone cement

Publications (2)

Publication Number Publication Date
AU2001266460A1 AU2001266460A1 (en) 2003-05-15
AU2001266460B2 true AU2001266460B2 (en) 2005-09-29

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Family Applications (1)

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AU2001266460A Ceased AU2001266460B2 (en) 2001-06-14 2001-06-14 Method and device for preparation of bone cement

Country Status (9)

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US (1) US6648499B2 (en)
EP (1) EP1395208B1 (en)
JP (1) JP2004528948A (en)
AU (1) AU2001266460B2 (en)
CA (1) CA2449970A1 (en)
DE (1) DE60126156T2 (en)
DK (1) DK1395208T3 (en)
NO (1) NO322389B1 (en)
WO (1) WO2002102286A1 (en)

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EP1395208B1 (en) 2007-01-17
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US6648499B2 (en) 2003-11-18
DE60126156D1 (en) 2007-03-08
CA2449970A1 (en) 2002-12-27
WO2002102286A1 (en) 2002-12-27
DK1395208T3 (en) 2007-05-07
US20020191485A1 (en) 2002-12-19
JP2004528948A (en) 2004-09-24
NO322389B1 (en) 2006-09-25

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